RecruitingNot ApplicableNCT06699875

Conventional Therapy vs. Telerehabilitation With TRAK in Patients Undergoing Axillary Lymph Node Removal

Comparative Study of the Effectiveness Between Models of Conventional Therapy vs Telerehabilitation With TRAK in Patients Undergoing Axillary Lymph Node Removal (Axillary Lymphadenectomy) as Part of Therapy Against Breast Cancer.


Sponsor

Trak Health Solutions S.L.

Enrollment

40 participants

Start Date

May 16, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to compare the effectiveness of digital physiotherapy via Trak telerehabilitation with conventional home-based exercises in women who have undergone axillary lymph node removal (axillary lymphadenectomy) as part of breast cancer treatment. Researchers will compare the Trak telerehabilitation platform to a standard home exercise protocol to assess the impact on shoulder mobility, treatment adherence, and overall patient satisfaction. Participants will undergo a 4-week home-based rehabilitation using Trak (treatment group) or follow a paper-based exercise protocol (control group) and attend follow-up visits to measure shoulder mobility and any necessary adjustments in treatment.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing a standard in-person physiotherapy program with a telerehabilitation app (TRAK) for women who have had lymph nodes removed from their armpit during breast cancer surgery, to see if remote digital rehabilitation is just as effective for shoulder and arm recovery. **You may be eligible if...** - You are a woman 18 years or older - You have had axillary lymph node removal (lymphadenectomy) as part of your breast cancer treatment - You have access to a tablet, smartphone, or laptop (or have family support) - You have an email account or are willing to create one - You have signed the informed consent form **You may NOT be eligible if...** - You have cognitive difficulties that would prevent you from using the app - You are currently receiving chemotherapy after lymph node surgery - You have a pre-existing shoulder problem (such as rotator cuff tear, chronic pain, or previous shoulder surgery with limited mobility) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERTrak exercise prescription protocol at home

Online exercise protocol using the TRAK software. The patient will undergo 4 weeks of an exercise prescription protocol based on shoulder mobility exercises.

OTHERConventional rehabilitation plan at home

Treatment is based on therapeutic exercise following a conventional rehabilitation plan on paper. The patient will undergo 4 weeks of an exercise prescription protocol based on mobility exercises.


Locations(1)

Donostia University Hospital (HU Donostia, OSI Donostialdea)

Donostia / San Sebastian, Basque Country, Spain

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NCT06699875


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